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NCT04737421 · ClinicalTrials.gov registry record
A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
A clinical trial of Marginal Bone Level Change, sponsored by Nobel Biocare.
- Active
- Registry status
- 1,000
- Enrollment target
- 20
- Study locations
NCT04737421: Active study of Marginal Bone Level Change, sponsored by Nobel Biocare.
NCT04737421 is a study of Marginal Bone Level Change that is active but no longer recruiting, run by Nobel Biocare. The registered enrollment target is 1,000 participants. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04737421, a study of Marginal Bone Level Change, is active but no longer recruiting, sponsored by Nobel Biocare.
- ACTIVE NOT RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement
Primary Outcome
The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.
Conditions Studied
Interventions
- DEVICE NobelActive TiUltra implant
- DEVICE NobelParallel CC TiUltra implants
- DEVICE NobelReplace CC TiUltra implants
- DEVICE Nobel Biocare N1 TiUltra TCC implants
Study Locations (20)
Other
- Melbourne Dental School The University of Melbourne - Melbourne
- Akademie für orale Implantologie GmbH & Co - Vienna
- Implantologie und Ästhetische Zahnheilkunde - Vienna
- Dental Center Helmiäinen - Tampere
- Cabinet du Dr Noharet - Lyon
- BGLP - Montpellier
- IFCIA - Paris
- DrS - Schöne Zähne - Dr. Scherg Praxis für Implantologie & Ästhetik - Karlstadt am Main
- Studio Odontoiatrico Specialistico Ban Mancini Fabbri - Cattolica
- UOC di Chirurgia Maxillo-Facciale e Odontoiatria - Verona
- Staas & Bergmans Zorgvooruwmond B.V. - 's-Hertogenbosch
- ParoBrea- Parodontologie & Implantologie - Breda
Illinois
- Northwest Oral and Maxillofacial Surgery - Arlington Heights
- Midwest Dental Implantology - Saint Charles
Alabama
- Madison Prosthodontics - Madison
New York
- New York Center for Orthognathic and Maxillofacial Surgery - New York
Oregon
- Periodontal Associates - Tualatin
New South Wales
- Dentartisans Pty ltd - Pyrmont
Perth
- Bc Prosthodontics - West Perth
Herning
- Herning Implantat Center - Herning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2029-05-31 |
What the registry record for NCT04737421 still lists
NCT04737421 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Marginal Bone Level Change appearing as the primary indexed condition, and to 4 interventions - of which NobelActive TiUltra implant is the first listed.
NCT04737421 names 20 study sites across 8 states, led by Other, Illinois, Alabama.
Frequently Asked Questions
What is clinical trial NCT04737421 about?
NCT04737421 is a clinical study titled "A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components". This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferi...
What is the current status of trial NCT04737421?
This trial is currently active not recruiting. The enrollment target is 1,000 participants. The study started on 2021-05-26. Estimated completion is 2029-05-31.
What conditions does trial NCT04737421 study?
This clinical trial studies the following conditions: Marginal Bone Level Change.
What interventions are being tested in trial NCT04737421?
The interventions under investigation include: NobelActive TiUltra implant (DEVICE), NobelParallel CC TiUltra implants (DEVICE), NobelReplace CC TiUltra implants (DEVICE), Nobel Biocare N1 TiUltra TCC implants (DEVICE).
Who is sponsoring clinical trial NCT04737421?
This trial is sponsored by Nobel Biocare, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04737421 being conducted?
This trial has 20 study locations across Alabama, Illinois, New York, Oregon, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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